DELP for Acute Hemorrhagic Stroke

Phase 2

Terminated

• Conditions: Cerebral Hemorrhage
• Interventions: Device: Delipid Extracorporeal Lipoprotein filter from Plasma

• Registration Number: NCT04708990
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). Our recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, we argue that DELP may exert neuroprotective effect on acute cerebral hemorrhage.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-11
• Study Start: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age: 18-80;
• Spontaneous cerebral hemorrhage;
• Deep supratentorial intracerebral hemorrhage (basal ganglia and thalamus) with hematoma volume 5-40ml;
• NIHSS: 4-22;
• Time from onset to DELP is less than 48 hours;
• Premorbid mRS 0 or 1;
• Signed informed consent;

Exclusion Criteria

• Secondary cerebral hemorrhage (secondary to trauma, tumor, vascular malformation, hemorrhage transformation of ischemic stroke, etc.);
• Comatose patients on admission (GCS score 3-8 on the Glasgow Coma Scale);
• Patients with intracerebral hemorrhage ruptured into the ventricle;
• Planed surgery;
• Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
• Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
• Previous allergy to heparin or calcium;
• hypoproteinemia;
• Unsuitable for this clinical studies assessed by researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DELP	Delipid Extracorporeal Lipoprotein filter from Plasma	Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration

Primary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Score 0 to 2	Day 90

Secondary Outcome Measures

Name	Time	Method
the occurence of death due to any cause	Day 90
Proportion of patients with modified Rankin Score 0 to 1	Day 90
Changes in national institutes of health stroke scale (NIHSS)	48 hours	NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.
changes of hematoma volume compared with the baseline	48 hours
changes of edema volume around hematoma compared with the baseline	48 hours

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China